Generic Name: prenatal vitamin
Dosage Form: softgel
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
PRENATE® Pixie 75854-0316
DESCRIPTION: PRENATE® PIXIE is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”.
Serving Size: 1 Softgel
|Amount per Serving:||% Daily
|Vitamin C (as ascorbic acid)||30 mg||50%||50%|
|Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg)||1 mg||250%||125%|
|Iron (as ferrous asparto glycinate) Sumalate®||10 mg||56%||56%|
|Iodine (as potassium iodide)||150 mcg||100%||100%|
|Vitamin B6 (as pyridoxine HCl)||5 mg||250%||200%|
(as dl-alpha tocopheryl acetate)
|Docosahexaenoic acid (DHA)||200 mg||†||†|
† Daily Value (DV) not established.
PRENATE® PIXIE contains fish oil and soy.
OTHER INGREDIENTS: Bovine gelatin, glycerin, yellow beeswax, soy lecithin, vegetable shortening, purified water, titanium dioxide, FD&C Red #40, caramel and FD&C Blue #1.
INDICATIONS: PRENATE® PIXIE is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.
CONTRAINDICATIONS: PRENATE® PIXIE is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
HOW SUPPLIED: Bottles of 30 softgels (75854-0316-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.
PRENATE®Pixie is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 softgel container image
Robust Rx Prenatal Vitamin with
11 concentrated nutrients and minerals
in a tiny softgel package
ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated
|Labeler - Avion Pharmaceuticals, LLC (965450542)|